Cannabis extracts and methods of preparing and using same

ABSTRACT

The invention relates to the extraction of pharmaceutically active components from plant materials, and more particularly to the preparation of a botanical drug substance (BDS) for incorporation in to a medicament. It also relates to a BDS, for use in pharmaceutical formulations. In particular it relates to BDS comprising cannabinoids obtained by extraction from cannabis.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/919,245, filed Oct. 21, 2015, and claims priority to and the benefitof U.S. Provisional Application No. 62/066,795 filed on Oct. 21, 2014and U.S. Provisional Application No. 62/068,278 filed on Oct. 24, 2014,the contents of which are incorporated by reference in their entireties.

FIELD OF THE INVENTION

This invention relates to the extraction of pharmaceutically activecomponents from plant materials, and more particularly to botanical drugsubstance (BDS) comprising cannabinoids obtained by extraction fromcannabis. Methods of using the extracts to treat chronic pain,paralysis, neuropathy, Crohn's Disease, IBS, glaucoma, PTSD, anxiety,seizures, epilepsy, autoimmune disorders autism, tumors, and cancer arealso included.

BACKGROUND OF THE INVENTION

Cannabis products have been consumed in various forms for thousands ofyears. The first descriptions of the medical uses date from Chineseherbal texts in the first century A.D. Cannabis products were takenorally in an herbal tea concoction and were used for theirpain-relieving and sleep-inducing properties.

There presently exists the need to provide more effective and safercannabis extracts for various medical uses, extraction methods thatprovide unique active compounds that are useful to treat pain andvarious medical conditions. Additionally, presently known extractionprocedures do not provide the desired active ingredient(s) for theparticular medical purpose. The present invention overcomes theselimitations and provides other related advantages.

SUMMARY OF THE INVENTION

The invention provides an extract comprising a mixture of at least 95%total cannabinoids, and at least one terpene/flavonoid. The extractcontains at least 4, 5, 6 , 7 or more cannabinoids. The cannabinoids areselected from tetrahydrocannabinolic acid (THCa), cannabidiolic acid(CBDa), cannabinolic acid (CBNa) cannabichromenic acid (CBCa),tetrahydrocannabinol (THC), cannabinol (CBN), cannabidiol (CBD) orcannabichromene (CBC). In some aspect the cannabinoids are THCa and CBDaand at least two cannabinoids selected from CBNa, CBCa, THC, CBN andCBC. In a preferred embodiment the cannabinoids are THC, CBN, CBC andCBD. In another preferred embodiment the cannabinoids are THCa, CBDa,CBNa and CBCa. In yet another preferred embodiment the cannabinoids areTHCa, CBDa, THC, CBN, and CBC.

The terpene/flavonoid is for example, d-limonene linalool, 1,8-cineole(eucalyptol), α-pinene, terpineol-4-ol, p-cymene, borneol, Δ-3-carene,β-sitosterol, β-myrcene, or β-caryophyllene.cannflavin A, apigenin,quercetin or pulegone.

Also provided by the invention are formulations containing the extractsaccording to the invention. For example the formulation contains any ofthe extracts according to the invention infused with a medium chaintriglyceride (MCT). The MCT is for example, NEOBEE 895.

Preferably, the pH of the formulation is at least pH 8.0.

In some formulations the concentration of THCa is greater than or equalto 95%; CBDa is less than 1%; CBNa is less than 3%; and CBCa is lessthan 1%. Optionally the formulation further contains d-limonene,linalool, 1,8-cineole (eucalyptol), α-pinene, terpineol-4-ol, p-cymene,borneol, Δ-3-carene, β-sitosterol, cannflavin A, apigenin, quercetin

In other formulations the concentration of THCa is less than or equal to35%; CBDa is greater than or equal to 60%; THC is less than 1%; CBN isless than 1%; and CBC is less than 1%. Optionally, the formulationfurther contains d-limonene, linalool, 1,8-cineole (eucalyptol),α-pinene, terpineol-4-ol, p-cymene, borneol, Δ-3-carene, β-sitosterol,cannflavin A, apigenin, quercetin

In another formulation the concentration of THCa is greater than orequal to 40%; CBDa is greater than or equal to 40%; THC is less than 1%;CBN is less than 1%; and CBC is less than 1%. Optionally, theformulation further contains β-myrcene, β-caryophyllene, pulegone,α-terpineol, β-sitosterol, cannflavin A, apigenin, quercetin

In yet another formulation the concentration of THC is less than orequal to 9%; CBD is greater than or equal to 40%; CBN is greater than orequal to 40%; and CBS is less than 1%. Optionally, the formulationfurther contains β-myrcene, β-caryophyllene, pulegone, α-terpineol,β-sitosterol, cannflavin A, apigenin, quercetin.

In various aspects the formulation of the invention are formulated for roral, sublingual, buccal, or topical administration. The sublingualformulation further contains a sweetener such as a Stevia extract.Optionally, the sublingual formulation further contains lemon oil,orange oil or both.

In other aspects the invention provides a method of preparing acannabisextract providing fresh or live cannabis plant material;extracting the cannabinoids from the plant material to produce a firstextract; winterizing and purging the winterized extract. Optionally, themethod further includes decarboxylating the phytocannabinoids prior toextraction. The decarboxylation is accomplished for example, by heatingthe dried plant material at a temperature of about 221° F. for at least15 minutes followed by heating at about 284° F. for at least 45 minutes.In some aspects the winterized extract is heated at 284° F. for at about45-74 minutes followed by heating at about 293° F. for at least about55-90 minutes.

Extraction is for example by hydrocarbon extraction. Winterizingincludes adding cold ethanol to the first extract or storing the firstextract at a temperature of about −20° to about −75° F. for about 48hours to produce a waxy precipitate and removing the waxy precipitate byfiltration. Optionally, the winterized extract is filtered throughactivated charcoal.

The cannabis plant material consists of flowers or flowers and leaves.In some aspects the cannabis plant material is frozen at a temperaturebetween at least −10° F. to −50° F. for at least 36 hours prior to beingextracted. Preferably, the cannabis plant material has been propagatedfrom a single seed source or a tissue culture with specific ratios ofcannabinoids. In some aspects the cannabis plant material is derivedfrom a cannabis strain having a minimum of 15% THC and less that 1% CBD.In others aspect the cannabis plant material is derived from SourTsunami x Catatonic Sour Tsunami x Sour Tsunami, Sour Tsunami,Harlequin, R4 ACDC strains. In yet other as aspects the cannabis plantmaterial is derived from CBD1, Sour Pineapple, CBD Diesel, Harlequin,ACDC or R4. In yet a further aspect the cannabis plant material isderived from Sour Tsunami x Catatonic, Sour Tsunami x Sour Tsunami, SourTsunami, Harlequin, R4, Swiss Gold, ACDC, CBD1, Sour Pineapple, or CBDDiesel.

The invention further provides a method for preparing cannabis juice byblanching fresh cannabis leaves obtained from a cannabis plant in thevegetative stage in cold water; juicing the leaves in a cold pressjuicer or masticating juicer; and filtering the juice through a filterto remove particulates. Optionally, filter juice is freeze dried.

The juicer is for example, a cold press juicer or a masticating juicer.Also included in the invention is juice produced according to the methodof the invention. In some embodiments the cannabis juice is obtainedfrom cannabis flowers, cannabis roots or both.

The invention also provides method of relieving symptoms associated withanxiety, post traumatic stress disorder, chronic pain, or opiatedependency, paralysis, neuropathy, Crohns disease, inflammatory boweldisorders, glaucoma, seizures, epilepsy, autism, or cancer comprisingadministering to a subject in need thereof one or more of theformulations or juice according to the invention. The formulations areadministered four times daily. For example the formulation isadministered in the morning; afternoon, evening and at bedtime.

In specific embodiments the invention provides a method of treatingcancer by administering to a subject a total daily doses of: 20 mg ofcannabinoid extract and 50 mg of raw cannabis juice for seven days; 40mg of cannabinoid extract and 50 mg of raw cannabis juice for sevendays; 80 mg of cannabinoid extract and 50 mg of raw cannabis juice forseven days; 120 mg of cannabinoid extract and 50 mg of raw cannabisjuice for seven days; and 160 mg of cannabinoid extract and 100 mg ofraw cannabis juice for seven days. In some aspects the method furtherincludes administering a total daily dose of 200 mg cannabinoid extractand 100 mg of raw cannabis juice every day thereafter or administering200 mg of cannabinoid extract and 100 mg of raw cannabis juice for sevendays; and 400 mg of cannabinoid extract and 100 mg of raw cannabis juiceevery day thereafter.

In another embodiment the invention provides method of treating opioiddependency by reducing the amount of opiates used per day by at least10% and administering to a subject a total daily doses of: 31 mg ofcannabinoid extract and 50 mg of raw cannabis for fourteen days; 56 mgof cannabinoid extract and 50 mg of raw cannabis for fourteen days; 84mg of cannabinoid extract and 50 mg of raw cannabis juice for fourteendays; 104 mg of cannabinoid extract and 50 mg of raw cannabis forfourteen days; 89 mg of cannabinoid extract and 50 mg of raw cannabisfor fourteen days; 69 mg of cannabinoid extract and 50 mg of rawcannabis for fourteen days; 49 mg of cannabinoid extract and 50 mg ofraw cannabis for fourteen days; and 41 mg of cannabinoid extract and 50mg of raw cannabis for fourteen days.

Optionally, the method further includes administering a total daily doseof 36 mg cannabinoid extract and 25 mg of raw cannabis every daythereafter and a single dose of 50 mg raw cannabis every three days.

In another embodiment, the invention provides a method of treatinganxiety/PTSD by administering to a subject a total daily doses of about28 mg to 42 mg of cannabinoid extract.

In a further embodiment, the invention includes a method of treatingchronic pain by administering to a subject a total daily doses of about36 mg to 48 mg of cannabinoid extract.

The formulations are administered four times daily. For example, theformulation is administered in the morning; afternoon, evening and atbedtime.

Other features and advantages of the invention will be apparent from andare encompassed by the following detailed description and claims.

DETAILED DESCRIPTION

The present invention is based in part upon extraction procedures anddelivery approaches that allow selective utilization of variouscannabinoid molecules and terpenes from the whole cannabis sativa plant.These various cannabinoid compounds are designed to selectively affectvarious cannabinoid receptors in the nervous system, immune system andother tissues. The extract is an oil-based whole plant product thatcontains inactive and active compounds contained in the cannabis plantsuch as cannabinoids, terpenes and/or flavonoids. Compositions of theinvention and methods of extraction disclosed herein provide an extractwith specific physiological properties that are mediated throughseparate pathways and receptors, which provide numerous benefits andadvantages.

The extracts and/or delivery methods of the invention allows a widerange of prevention, treatment and management options for patients. Insome aspects the delivery methods of the invention employs micro-dosingwith a stacking method of cannabinoid administration week by week untila certain saturation point that is based on response, weight, andmonthly-quarterly test results.

Surprisingly, it was discovered that the age or the cannabis plantmaterial, the temperature in which it is stored and processed iscritical and the ratio of the specific cannabinoids extract is criticalto effectiveness of the final formulation. Importantly, for an extractto maintain non-psychoactive properties the cannabis plant material isnever heated above 160° F. Preferably, the non-psychoactive extractsaccording to the invention are formulated at 110° F. or below.

Cannabis is a genus of flowering plants that includes three differentspecies, Cannabis sativa, Cannabis indica and Cannabis ruderalis. Theterm “Cannabis plant(s)” encompasses wild type Cannabis and alsovariants thereof, including cannabis chemovars which naturally containdifferent amounts of the individual cannabinoids. For example, someCannabis strains have been bred to produce minimal levels of THC, theprincipal psychoactive constituent responsible for the high associatedwith it and other strains have been selectively bred to produce highlevels of THC and other psychoactive cannabinoids.

Cannabis plants produce a unique family of terpeno-phenolic compoundscalled cannabinoids, which produce the “high” one experiences fromconsuming marijuana. There are 483 identifiable chemical constituentsknown to exist in the cannabis plant, and at least 85 differentcannabinoids have been isolated from the plant. The two cannabinoidsusually produced in greatest abundance are cannabidiol (CBD) and/orΔ9-tetrahydrocannabinol (THC), but only THC is psychoactive. Cannabisplants are categorized by their chemical phenotype or “chemotype,” basedon the overall amount of THC produced, and on the ratio of THC to CBD.Although overall cannabinoid production is influenced by environmentalfactors, the THC/CBD ratio is genetically determined and remains fixedthroughout the life of a plant. Non-drug plants produce relatively lowlevels of THC and high levels of CBD, while drug plants produce highlevels of THC and low levels of CBD.

The best studied cannabinoids include tetrahydrocannabinol (THC),cannabidiol (CBD) and cannabinol (CBN). Other cannabinoids include forexample, cannabichromene (CBC), cannabigerol (CBG) cannabinidiol (CBND),Cannabicyclol (CBL), Cannabivarin (CBV), Tetrahydrocannabivarin (THCV),Cannabidivarin (CBDV), Cannabichromevarin (CBCV) Cannabigerovarin(CBGV), Cannabigerol Monomethyl Ether (CBGM).

Cannabinoids are derived from their respective 2-carboxylic acids(2-COOH) by decarboxylation (catalyzed by heat, light, or alkalineconditions). As a general rule, the carboxylic acids form of thecannabinoid have the function of a biosynthetic precursor.

As used herein THC, CBD, CBN, CBC, CBG, CBND, CBL, CBV, THCV, CBDV,CBCV, CBGV and CBGM refer to the decarboxylated form of the cannabinoid.Whereas, THCa, CBDa, CBNa, CBCa, CBGa, CBNDa, CBLa, CBVa, THCVa, CBDVa,CBCVa, CBGVa and CBGM refer to the acid form of the cannabinoid.

Tetrahydrocannabinol (THC) is the primary psychoactive component of theCannabis plant. THC is only psychoactive in is decarboxylated state. Thecarboxylic acid form (THCa) is non-psychoactive.

Delta-9-tetrahydrocannabinol (Δ9-THC, THC) anddelta-8-tetrahydrocannabinol (Δ8-THC), mimic the action of anandamide, aneurotransmitter produced naturally in the body. These two THCs producethe effects associated with cannabis by binding to the CB1 cannabinoidreceptors in the brain. THC appears to ease moderate pain (analgesic)and to be neuroprotective, while also offering the potential to reduceneuroinflammation and to stimulate neurogenesis. THC has approximatelyequal affinity for the CB1 and CB2 receptors.

Cannabidiol (CBD) is not psychoactive, and was thought not to affect thepsychoactivity of THC. However, recent evidence shows that smokers ofcannabis with a higher CBD/THC ratio were less likely to experienceschizophrenia-like symptoms.[15] This is supported by psychologicaltests, in which participants experience less intense psychotic-likeeffects when intravenous THC was co-administered with CBD (as measuredwith a PANSS test). Cannabidiol has little affinity for CB1 and CB2receptors but acts as an indirect antagonist of cannabinoid agonists.Recently it was found to be an antagonist at the putative newcannabinoid receptor, GPR55, a GPCR expressed in the caudate nucleus andputamen. Cannabidiol has also been shown to act as a 5-HT1 A receptoragonist, an action that is involved in its antidepressant, anxiolytic,and neuroprotective effects.

It appears to relieve convulsion, inflammation, anxiety, and nausea. CBDhas a greater affinity for the CB2 receptor than for the CB1 receptor.CBD shares a precursor with THC and is the main cannabinoid in low-THCCannabis strains. CBD apparently plays a role in preventing theshort-term memory loss associated with THC in mammals.

Cannabinol (CBN) is the primary product of THC degradation, and there isusually little of it in a fresh plant. CBN content increases as THCdegrades in storage, and with exposure to light and air. It is onlymildly psychoactive. Its affinity to the CB2 receptor is higher than forthe CB1 receptor

Cannabigerol (CBG) is non-psychotomimetic but still affects the overalleffects of Cannabis. It acts as an α2-adrenergic receptor agonist, 5-HT1A receptor antagonist, and CB1 receptor antagonist.[31] It also binds tothe CB2 receptor.[31]

Tetrahydrocannabivarin (THCV) is prevalent in certain central Asian andsouthern African strains of Cannabis. It is an antagonist of THC at CB1receptors and attenuates the psychoactive effects of THC.

Cannabidivarin (CBDV) is usually a minor constituent of the cannabinoidprofile.

Cannabichromene (CBC) is non-psychoactive and does not affect thepsychoactivity of THC. More common in tropical cannabis varieties.Effects include anti-inflammatory and analgesic.

In addition to cannabinoids, cannabis plants produce terpenes, a diversegroup of organic hydrocarbons that are the building blocks of thecannabinoids.

Over 100 different terpenes have been identified in the cannabis plant,and every strain tends toward a unique terpene type and composition. Theterpenes act synergistically with the cannabinoids to provide atherapeutic effect. Examples of some common terpenes found in Cannabisinclude:

Borneol—menthol, camphor, pine, woody. Can be easily converted intomenthol. It is considered a “calming sedative” in Chinese medicine. Itis directed for fatigue, recovery from illness and stress.

Caryophyllene—spicy, sweet, woody, clove, camphor, peppery. It bindsweakly to CB2 receptor. As a topical it is one of the constituents of ananti-inflammatory and analgesic treatment for toothache. In highamounts, it's a calcium and potassium ion channel blocker. As a result,it impedes the pressure exerted by heart muscles.

Cineole/Eucalyptol—spicy, camphor, refreshing, minty. It is used toincrease circulation, pain relief and easily crosses theblood-brain-barrier to trigger fast olfactory reaction.

Delta3Carene—sweet, pine, cedar, woodsy, pungent. In aroma therapy,cypress oil, high in D-3-carene, is used to dry excess fluids, tears,running noses, excess menstrual flow and perspiration.

Limonene—citrus (orange, tangerine, lemon, and grapefruit), rosemary,juniper, peppermint. Repulsive to predators. Found in the rinds of manyfruits and flowers. With the presence of other certain terpenes,Limonene can be an anti-bacterial, anti-fungal, anti-depressant andanti-carcinogen. It can synergistically promote the absorption of otherterpenes by quickly penetrating cell membranes. The result can beincreased systolic blood pressure.

Linolool—floral (spring flowers), lily, citrus and candied spice.Possesses anti-anxiety and sedative properties.

Myrcene—clove like, earthy, green-vegetative, citrus, fruity withtropical mango and minty nuances. The most prevalent terpene found inmost varieties of marijuana. It's a building block for menthol,citronella, and geraniol. It possesses antimicrobial, antiseptic,analgesic, antioxidant, anti-carcinogen, anti depressant,anti-inflammatory, and muscle relaxing effects. Myrcene affects thepermeability of the cell membranes, allowing more THC to reach braincells.

Pinene—Alpha: pine needles, rosemary Beta: dill, parsley, rosemary,basil, yarrow, rose, hops, the familiar odor associated with pine treesand their resins. Pinene can increase mental focus and energy, as wellas act as an expectorant, bronchodilator, and topical antiseptic. Iteasily crosses the blood-brain barrier where it inhibits activity ofacetylcholinesterase, which destroys acetylcholine, an informationtransfer molecule, resulting in better memory. It may counteract THC'sactivity, which leads to low acetylcholine levels.

Pulegone—mint, camphor, rosemary, candy. Pulegone is anacetylcholinesterase inhibitor. That is, it stops the action of theprotein that destroys acetylcholine, which is used by the brain to storememories.

In various aspects the invention provides cannabis extracts withpredefined ratios of cannabinoids. Standard conditions for cannabinoidassays, and methods of calculating cannabinoid content (as %) are wellknown in the art.

The extracts are mixture of at least 95% total cannabinoids and includeterpenes and/or flavonoids. Preferably the extracts contains a mixtureof at least cannabinoids four cannabinoid such as tetrahydrocannabinolicacid (THCa), cannabidiolic acid (CBDa), cannabinolic acid (CBNa)cannabichromenic acid (CBCa), tetrahydrocannabinol (THC), cannabinol(CBN), cannabidiol (CBD)and cannabichromene (CBC).

In some embodiments the extract contains THCa and CBDa and at least twocannabinoids selected from CBNa, CBCa, THC, CBN and CBC. In otherembodiments the extract includes THC, CBN, CBC and CBD. In furtherembodiments the extract includes THCa, CBDa, CBNa and CBCa. In otherembodiments the extract includes THCa, CBDa, THC, CBN, and CBC.

The terpene and/or flavonoids in the extract include for example,terpene is linalool, 1,8-cineole (eucalyptol), α-pinene, terpineol-4-ol,p-cymene, borneol, Δ-3-carene, β-sitosterol, β-myrcene,β-caryophyllene.d-limonene, cannflavin A, apigenin, quercetin orpulegone.

The extracts of the invention may be formulated with one or morepharmaceutically acceptable carriers, diluents or excipients ordeposited on a pharmaceutically acceptable surface for vaporisation inorder to produce pharmaceutical formulations containing cannabinoids asthe pharmaceutically active agents.

Therefore, in a further aspect the invention provides a method of makinga pharmaceutical composition comprising, as an active agent, a substancewhich is an extract from at least one cannabis plant variety.

Separate extracts may be prepared from single cannabis plant varietieshaving differing cannabinoid content (e.g. high THC and high CBD plants)and then mixed or blended together prior to formulation to produce thefinal pharmaceutical composition. This approach is preferred if, forexample, it is desired to achieve a defined ratio by weight ofindividual cannabinoids in the final formulation. Alternatively, plantmaterial from one or more cannabis plant varieties of definedcannabinoid content may be mixed together prior to extraction of asingle botanical drug substance having the desired cannabinoid content,which may then be formulated into a final pharmaceutical composition.

The extract may be formulated with any convenient pharmaceuticallyacceptable diluents, carriers or excipients to produce a pharmaceuticalcomposition. The choice of diluents, carriers or excipients will dependon the desired dosage form, which may in turn be dependent on theintended route of administration to a patient. Preferred dosage formsinclude, liquid dosage forms for administration via pump-action oraerosol sprays, tablets, pastilles, gels, capsules, suppositories,powders, etc. and vaporizers. Such dosage forms may be prepared inaccordance with standard principles of pharmaceutical formulation, knownto those skilled in the art.

Liquid formulations are particularly preferred. A particularly preferredformulation for administration of cannabinoids, though not intended tobe limiting to the invention, is a liquid formulation of the extractsaccording to the invention infused with a medium chain triglyceride(MCT). The MCT suitable for human consumption. The MCT may be composedof any combinations of C-6; C-8; C-10:C12 fatty acids. For example, theMCT is composed of 97%:3% C-8:C10; C-12 fatty acids (e.g., NEOBEE 895).Preferably the pH of the formulation is at least pH 8.0. Theformulations are suitable for oral, sublingual, buccal, or topicaladministration. When used for sublingual administration the formulationoptionally comprises a sweetener such as Stevia extract and or aflavoring such as for example lemon oil, orange oil or both.

A preferred formulation includes a cannabinoid mixture where THCa isgreater than or equal to 95%; a CBDa is less than 1%; CBNa is less than3%; and CBCa is less than 1%. In some aspects the formulation furtherincludes d-limonene, linalool, 1,8-cineole (eucalyptol), α-pinene,terpineol-4-ol, p-cymene, borneol, Δ-3-carene, β-sitosterol, cannflavinA, apigenin, and quercetin. This preferred formulation is referred toherein as PRANA 1.

Another preferred formulation includes a cannabinoid mixture where theTHCa is less than or equal to 35%; CBDa is greater than or equal to 60%;THC is less than 1%; CBN is less than 1%; and CBC is less than 1%. Insome aspects the formulation further includes d-limonene, linalool,1,8-cineole (eucalyptol), α-pinene, terpineol-4-ol, p-cymene, borneol,Δ-3-carene, β-sitosterol, cannflavin A, apigenin, and quercetin. Thispreferred formulation is referred to herein as PRANA 2.

In yet another preferred embodiment the formulation includes acannabinoid mixture where the THCa is greater than or equal to 40%; CBDais greater than or equal to 40%; THC is less than 1%; CBN is less than1%; and CBC is less than 1%. In some aspects the formulation furtherincludes β-myrcene, β-caryophyllene, pulegone, α-terpineol,β-sitosterol, cannflavin A, apigenin, and quercetin. This preferredformulation is referred to herein as PRANA 3.

In a further embodiment the formulation includes a cannabinoid mixtureTHC is less than or equal to 9%; CBD is greater than or equal to 40%;CBN is greater than or equal to 40%; and CBS is less than 1%. In someaspects the formulation further includes β-myrcene, β-caryophyllene,pulegone, α-terpineol, β-sitosterol, cannflavin A, apigenin, andquercetin. This preferred formulation is referred to herein as PRANA 4.

The extract is formulated for oral use (e.g. capsules) in dosage formsthat provide 5 mg, 10 mg, 20 mg, or 50 mg of total cannabinoids perdose. For sublingual use, the extract is formulated to provide 0.5, 1mg, or 2 mg, per drop.

In some applications, the patient may find it advantageous to activate(i.e., decarboxylate) the inactive (i.e. carboxylic acid form)cannabinoids in the extracts and formulations of the invention. Theinactive cannabinoids (e.g., THCa and CBDa) of the extracts andformulation of the invention can be converted to active cannabinoids(THC and CBD) by heating the extracts and formulation at a temperatureabove 160° F. For example, a vessel containing the extracts andformulations of the invention are placed in boiling water (212° F.) forabout 30 minutes.

According the invention further contemplates extracts and formulationsthereof having the same ratio of cannabinoids as PRANA 1, PRANA 2 andPRANA3 where the THA and the CBD is in its activated decarboxylatedform.

The methods of the invention may be used to prepare a cannabinoid-richextract from cannabis plant material. The method includes providingfresh or live cannabis plant material; extracting the cannabinoids fromthe fresh or live plant material to produce a first extract; winterizingthe first to produce a winterized extract and purging the winterizedextract to produce a cannabis extract. Optionally, the method includesdecarboxylating the phytocannabinoids prior the extraction step.

Decarboxylation of cannabinoid acids is a function of time andtemperature, thus at higher temperatures a shorter period of time willbe taken for complete decarboxylation of a given amount of cannabinoidacid. In selecting appropriate conditions for decarboxylationconsideration must, however, be given to minimising thermal degradationof the desirable, pharmacological cannabinoids into undesirabledegradation products, particularly thermal degradation of THC tocannabinol (CBN). Preferably, decarboxylation is carried out in amulti-step heating process. For example, Phytocannabinoids aredecarboxylated for example by heating the dried plant material at atemperature of about 221° F. for at least 15 minutes followed by heatingat about 284° F. for at least 45 minutes. Other suitable methods ofdecarboxylating phytocannabinoids known in the art may be used.

In some aspects resultant cannabis extract is heated at 284° F. for atabout 45-74 minutes followed by heating at about 293° F. for at leastabout 55-90 minutes.

The cannabis plant material consists of flowers or flowers and leaves.Preferably, the cannabis plant material is frozen at a temperaturebetween at least −10° F. to −50° F. for at least 36 hours prior to beingdried.

The cannabis plant material has been propagated from a single seedsource or a tissue culture or clone with specific ratios ofcannabinoids.

Any suitable method for extraction known in the art may be used. Forexample extraction is hydrocarbon extraction, supercritical C02 orNEOBEE 896 MCT.

The first extract may be winterizing by any method known in the art. Forexample the first extract is winterized by comprises adding cold ethanolor by storing the first extract at temperature of about −20° F. to about−75° F. for about 48 hours. Winterization produces a waxy precipitate.The waxy precipitate is removed by filtration. Optionally, thewinterized extract through activated charcoal.

In some aspects the cannabis plant material is derived from a cannabisstrain having a minimum of 15% THC and less that 1% CBD. In otheraspects the cannabis plant material is derived from cannabis strainshaving a minimum of 10% CBD and less than 10% THC. For example thecannabis plant material is derived from Sour Tsunami x Catatonic SourTsunami x Sour Tsunami, Sour Tsunami , Harlequin, R4 or ACDC strains. Inother embodiments the cannabis plant material is derived from CBD1, SourPineapple, CBD Diesel, Harlequin, ACDC or R4. In yet another embodimentthe cannabis plant material is derived from Sour Tsunami x Catatonic,Sour Tsunami x Sour Tsunami, Sour Tsunami, Harlequin, R4, Swiss Gold,ACDC, CBD1, Sour Pineapple, or CBD Diesel.

The invention also provides a method for preparing cannabis juicecomprising blanching fresh cannabis leaves obtained from a cannabisplant in the vegetative stage in cold water; juicing the leaves in acold press juicer or masticating juicer; filtering the juice through afilter to remove particulates. Optionally, the juice freeze dried. Thejuicer is a cold press juicer or a masticating juicer. In some aspectsthe juice further includes cannabis juice obtained from cannabisflowers, cannabis roots or both.

The juice of raw cannabis provides unique healing benefits. Plantchemicals known as cannabinoid acids such as CBD-acids, and THC-acidsbreak down quickly after harvest, so these compounds are not availablein traditional preparations such as cooked ‘medibles’, smoking, orvaporizing The healing benefits of cannabinoid-acids are only presentfor a short period of time before the chemicals break down, so juicingneeds to be done quickly after harvest. Fan leaves should make up themajority of the juice, and adding a small amount of cannabis flowers canbe beneficial.

Cannabis extracts and juice have wide-ranging beneficial effects on anumber of medical conditions.

Chronic pain, paralysis, neuropathy, Crohn's Disease, inflammatory boweldisorders (IBS and IBD), glaucoma, PTSD, anxiety, seizures, epilepsy,autoimmune disorders, autism, tumors, and cancer have all been shown byseveral studies to be controlled by use of Cannabis. In addition, nauseaand vomiting that are unresponsive to other medications have been shownto be helped through the use of Cannabis. Dependency on opiates havealso been shown to be controlled by the use of Cannabis

Accordingly the invention also includes methods of alleviating a symptomassociated with anxiety, post-traumatic stress disorder, chronic pain,or opiate dependency, paralysis, neuropathy, Crohn's disease,inflammatory bowel disorders, glaucoma, seizures, epilepsy, autism, orcancer comprising administering to a subject any one of the formulationaccording to the invention. In some embodiments the subject receivesboth a formulation containing a cannabis extract and raw cannabis in theform of a juice.

In some embodiments the formulation are administered four times daily.For example, the formulations are administered in the morning,afternoon, evening and at bedtime. The formulations are administeredsuch that the ratio of cannabinoids are different depending upon thetime of day administered. For example, formulations containing loweramounts of THC (and higher amounts of THCa) are administered duringwaking hours of the day. Whereas, formulations containing higher amountsof THC (and lower amounts of THCa) are administered prior to bedtime.Exemplary day time formulations include a cannabinoid mixture where THCais greater than or equal to 95%; a CBDa is less than 1%; CBNa is lessthan 3%; and CBCa is less than 1%; a cannabinoid mixture where the THCais less than or equal to 35%; CBDa is greater than or equal to 60%;THCis less than 1%; CBN is less than 1%; and CBC is less than 1%; or acannabinoid mixture where the THCa is greater than or equal to 40%; CBDais greater than or equal to 40%; THC is less than 1%; CBN is less than1%; and CBC is less than 1%. An exemplary bedtime formulation includes acannabinoid mixture THC is less than or equal to 9%; CBD is greater thanor equal to 40%; CBN is greater than or equal to 40%; and CBS is lessthan 1%.

Preferably a formulation including a cannabinoid mixture where THCa isgreater than or equal to 95%; a CBDa is less than 1%; CBNa is less than3%; and CBCa is less than 1% is administered in the morning. Preferablya cannabinoid mixture where the THCa is less than or equal to 35%; CBDais greater than or equal to 60%; THC is less than 1%; CBN is less than1%; and CBC is less than 1% is administered in the afternoon.Preferably, a cannabinoid mixture where the THCa is greater than orequal to 40%; CBDa is greater than or equal to 40%; THC is less than 1%;CBN is less than 1%; and CBC is less than 1% is administered in theevening.

In various aspects the method of the invention include administering thecannabinoids containing compounds by employing an escalating dosingregimen where the total amount of cannabinoids are increased over time.For example, the amount of cannabinoids administered is increased weekby week until a certain saturation point that is based on response,weight, and monthly-quarterly test results. To treat opioid dependency,opiates are gradually replaced cannabinoids.

In a preferred method cancer is treated by administering to a subject atotal daily doses of:

-   -   a. 20 mg of cannabinoid extract and 50 mg of raw cannabis juice        for seven days;    -   b. 40 mg of cannabinoid extract and 50 mg of raw cannabis juice        for seven days;    -   c. 80 mg of cannabinoid extract and 50 mg of raw cannabis juice        for seven days;    -   d. 120 mg of cannabinoid extract and 50 mg of raw cannabis juice        for seven days; and    -   e. 160 mg of cannabinoid extract and 100 mg of raw cannabis        juice for seven days.

In some embodiments, this dosing regimen is followed by administeringthe subject a total daily dose of 200 mg cannabinoid extract and 100 mgof raw cannabis juice every day thereafter. In another embodiment thisdosing regimen is followed by administering the subject 200 mg ofcannabinoid extract and 100 mg of raw cannabis juice for seven days; and400 mg of cannabinoid extract and 100 mg of raw cannabis juice every daythereafter.

EXAMPLES Example 1 Preparation & Storage of Cannabis

Fresh cannabis plant material (flowers/flower leaves) is harvested fromplants propagated from cuttings taken from the mother plants,originating from a single seed source or tissue culture with specificstarting ratio's of cannabinoids

Cannabis Plant material (flowers/flower leaves) is stored in a freshfrozen state immediately after harvesting.

Preferably the plant material is flash frozen for 10 minutes at atemperature between −10° F. and −50° F. The plant material is stored invacuum seal bags for a minimum of 36 hrs prior to extraction. Thestarting cannabis plant material is extracted at a 90% cannabinoidand/or phytocannabinoid concentrated form.

Example 2 Extraction of Inactive Cannabinoids

Cannabis flowers stored in a flash frozen state (see Example 1), andgently spread apart on curing screens while still in a frozen state.Gently break apart and spread the fresh frozen plant material into smallsized pieces less than 0.7 inches on a 160u-220u screen to be air driedout.

The plant material (inactive plant matter) is placed in a stainlesssteel cylinder inside a closed loop hydrocarbon extraction machine suchas the Emotek Obe Dos, or equal supercritical C0₂ extractionequipment/methods that meet these specific requirements.

Liquid hydrocarbon (99%) is run thru the product and held under pressureof (45 pounds of pressure) for approximately 45 min at a temperature−20° F. Fahrenheit to −75° F.

The result material is winterized to remove inert waxy material.Winterization is accomplished by applying a secondary gas to the liquidhydrocarbon; a cold ethanol wash that is filtered out, or by storing theextract solution at −20° F. to −75° F. for approximately 48 hrs. Theresultant waxy precipitate is removed by filtration through a twenty μmmembrane and passed through activated charcoal.

Finally, the extract is purged under a vacuum pressurized unit AcrossInternational Digital Vacuum Drying Oven with a solvent rated recoverypump with a min ½ hp 3425 rip oil-less compressor for approximately 48hrs.

The final product is removed and stored in amber glass storagecontainers without light exposure and stored at temps below 40° F. untilneeded for formulation of products.

Example 3 Extraction of Active Cannabinoids

Cannabis flowers are air dried as in Example 2. Once the cannabisflowers are air dried the cannabis plant material is placed in ascientific sterile containment oven for 15 min @ 221° F. degrees, andagain at 284° F. degrees for 45 min. The process in order decarboxylatesthe phytocannabinoids. Once the cannabis plant material has beendecarboxylated it is extracted in an ACTIVE

The fresh cannabis plant material (ACTIVE plant material) is placed in astainless steel cylinder inside a closed loop hydrocarbon extractionLiquid hydrocarbon (99%) is run thru the product and held under pressureof (45 pounds of pressure) for approximately 45 min at a temperature−20° F. Fahrenheit to −75° F.

The result material is winterized to remove inert waxy material.Winterization is accomplished by applying a secondary gas to the liquidhydrocarbon; a cold ethanol wash that is filtered out, or by storing theextract solution at −20° F. to −75° F. for approximately 48 hrs. Theresultant waxy precipitate is removed by filtration through a twenty μmmembrane and passed through activated charcoal.

Finally, the extract is purged under a vacuum pressurized unit AcrossInternational Digital Vacuum Drying Oven with a solvent rated recoverypump with a min ½ hp 3425 rip oil-less compressor for approximately 48hrs.

The resultant decarboxylated CBD:THC oil is converted to CBD:CBN(defined as >90% CBD:THC) oil by heating the oil at 284° F. for 45-75minutes, and a second temperature at 293° F. for 55 min-90 min.

The final product is removed and stored in amber glass storagecontainers without light exposure and stored at temps below 40° F. untilneeded for formulation of products.

Example 3 Extraction Using NEOBEE 895 MCT

Start with cured and dried cannabis flowers, flower rosin, hash rosin,hashish, or kif with specific starting ratio's of cannabinoids 1:1, 2:1,3:1, 4:1, 8:1, 18:1, 20:1, 30:1, 50:1, 70:1. Cannabis flowers should bedried out with a moisture content of below 3% and gently broken apartinto small sized pieces less then 0.7 inches, or finely milled into 2 mmto 3 mm sized pieces. Cannabis flowers, flower rosin, hash rosin,hashish, or kif are combined with NEOBEE 895 MCT. The ratio of cannabisto MCT is determined based on the starting material, test results,ratio's, and desired mg per ml outcome. Example 50 g of 20% Cannabisflowers combined with 100 ml of MCT oil. The MCT Oil and startingcannabis material is heated together in a brewer, double boiler, or on aheat plate at 41 Celsius/106 Fahrenheit for a minimum of 3 hrs in orderto extract and infuse the desired cannabinoids into the MCT oil. The oilis strained thru a 15 micron stainless steel filter, or silk screen toseparate the cannabis content from the oil. Utilizing a Buchner funneland 5 micron filtration system under vacuum will provide the bestresults for flirtation. The soaked cannabis content is pressed to removeall remaining oil, filtered, and added back to the concentrated infusedTHCa and/or CBDa NEOBEE 895 MCT mixture. This initial mixture isconsidered a INACTIVE state since the cannabinoids are still in the acidforms of THCa and/or CBDa. The infused cannabis and NEOBEE 895 MCT oilcan be heated at 105 celsius/221 Fahrenheit for 15 min, and repeated at140 celsius/284 fahrenheit 45 min-120 min to ACTIVATE thephytocannabinoids into THC and/or CBD. Decarboxylate cannabis flowers,flower rosin, hash rosin, hasish, or kif THC, or CBN, can also becombined to the NEOBEE 895 MCT and heated together at 41 Celsius/106Fahrenheit for a minimum of 3 hrs in order to infuse the ACTIVE contentinto the MCT oil. This process is used to create all products withspecific ratio's and milligram to milliliter dosages for capsules,sublingual's, topical, transdermal, etc.

Example 4 Flower & Hash Rosin Extraction

Cannabis flowers are cured until moisture is below 10%. Once thecannabis flowers are air dried the cannabis plant material is placed ina stainless steel, or nylon silk screen sleeves with a micron ratingsranging including 15u, 25u, 90u, and 120u. Desired micron rating is usedbased on the starting material flower vs separated trichome heads onlyknown as bubble hash or kif. The flowers, hash, or kif in these sleevesare placed between PTFE 3× flourmer coated sheets, or non-stickparchment paper. The sheets are a min of 2× wider then the nylon orstainless steel screens to collect the extracted cannabinoid oils andresin. A mechanical heat platen press is used with min pressure of 2500psi with heat applied at ranges between 100-300 degree's for a range of4 seconds to 3 min depending on the desired out come. This processmechanically separates the cannabinoids and terpenes present in the rawcannabis flowers with concentrations of THCa, THC, CBDa, CBD, CBGa, CBG,CBN, CBL. The resin is collected from the PTFE or non stick parchmentpaper, weighed, and stored in a plastic seal bag or glass Pyrex attemperatures of 32 degrees Fahrenheit or below. This type ofmechanically separated cannabis resin and extract is later combined withNEOBEE 895 MCT to make desired formulations, ratio's, and concentrationsfor the various delivery methods described in this document i.e.capsule, topical, transdermal, sublingual.

Example 5 Preparation of Raw Cannabinoids

Plants with high CBD content are best for juicing as they contain moreCBD-acids than non-CBD producing strains.

Process:

-   -   1. We remove ONLY fresh cannabis leaves during vegetation NOT        during the flowering cycle.    -   2. Leaves are blanched in cold water for cleaning    -   3. Leaves are then juiced using a cold press juicer or        commercial masticating juice    -   4. The juice is filtered thru a stainless steel filter to remove        any particulates.    -   5. Juice is immediately poured into 1 oz containers or 10 oz        containers and freeze-dried at −50° F. degrees.    -   6. Freeze-dried cannabis juice can be used in capsule form,        packets, or infused with a medical food.

Example 6 Formulation of Cannabis Extracts

Mix 1 gram of cannabis oil produced by the above methods with a min of95% total cannabinoid concentration per 40 ml of NEOBEE 895 forapproximately 24 hrs at a temperature under 90° F. but not lower than70° F. without exposure to light. The resultant infusion is mixed withNEOBEE 895 to produce capsules at 5 mg, 10 mg, 20 mg, and 50 mg totalcannabinoids. For subligual formulations 0.5 g or 350 mg of theresultant infusion is combined with 9 ml of NEOBEE 895 and 1 ml ofnatural sweeteners and flavor additives. (Stevia, truvia, xyotol, lemon,orange)

Example 7 Exemplary Stacking Protocol For Cancer/Tumor Treatment andManagement

WEEK #1

Morning:

+Frozen ¼ ounce of proprietary blend of Fresh Frozen Raw Cannabis Juice(50 mg Raw) or Powdered Raw Cannabis Juice added to apple juice, supersmoothie, or anti-inflammatory juice beverage.

+5 mg Prana P1 Capsules

Afternoon:

+5 mg Prana P2 Capsules

Dinner:

+5 mg Prana P3 Capsules

Bedtime: (30 min Prior)

+5 mg Prana P4 Capsules

TOTAL CANNABINOIDS ABSORBED DAILY: 20 mg+50 mg Raw

WEEK #2

Morning:

+Frozen ¼ ounce of proprietary blend of Fresh Frozen Raw Cannabis Juice(50 mg Raw) or Powdered Raw Cannabis Juice added to apple juice, supersmoothie, or anti-inflammatory juice beverage.

+10 mg Prana P1 Capsules

Afternoon:

+10 mg Prana P2 Capsules

Dinner:

+10 mg Prana P3 Capsules

Bedtime: (30 min Prior)

+10 mg Prana P4 Capsules

TOTAL CANNABINOIDS ABSORBED DAILY: 40 mg+50 mg Raw

WEEK #3 (MIN HOLDING DOSE)

Morning:

+Frozen ¼ ounce of proprietary blend of Fresh Frozen Raw Cannabis Juice(50 mg Raw) or Powdered Raw Cannabis Juice added to apple juice, supersmoothie, or anti-inflammatory juice beverage.

+20 mg Prana P1 Capsules

Afternoon:

+20 mg Prana P2 Capsules

Dinner:

+20 mg Prana P3 Capsules

Bedtime: (30 min Prior)

+20 mg Prana P4 Capsules

TOTAL CANNABINOIDS ABSORBED DAILY: 80 mg+50 mg Raw

WEEK #4

Morning:

+Frozen ¼ ounce of proprietary blend of Fresh Frozen Raw Cannabis Juice(50 mg Raw) or Powdered Raw Cannabis Juice added to apple juice, supersmoothie, or anti-inflammatory juice beverage.

+30 mg Prana P1 Capsules

Afternoon:

+30 mg Prana P2 Capsules

Dinner:

+30 mg Prana P3 Capsules

Bedtime: (30 min Prior)

+30 mg Prana P4 Capsules

TOTAL CANNABINOIDS ABSORBED DAILY: 120 mg+50 mg Raw

WEEK #5

Morning:

+Frozen 0.5 ounce of proprietary blend of Fresh Frozen Raw CannabisJuice (100 mg Raw) or Powdered Raw Cannabis Juice added to apple juice,super smoothie, or anti-inflammatory juice beverage.

+40 mg Prana P1 Capsules

Afternoon:

+40 mg Prana P2 Capsules

Dinner:

+40 mg Prana P3 Capsules

Bedtime: (30 min Prior)

+40 mg Prana P4 Capsules

TOTAL CANNABINOIDS ABSORBED DAILY: 160 mg+100 mg Raw

WEEK #6 (ADVANCED HOLDING DOSE)

Morning:

+Frozen 0.5 ounce of proprietary blend of Fresh Frozen Raw CannabisJuice (100 mg Raw) or Powdered Raw Cannabis Juice added to apple juice,super smoothie, or anti-inflammatory juice beverage.

+50 mg Prana P1 Capsules

Afternoon:

+50 mg Prana P2 Capsules

Dinner:

+50 mg Prana P3 Capsules

Bedtime: (30 min Prior)

+50 mg Prana P4 Capsules

TOTAL CANNABINOIDS ABSORBED DAILY: 200 mg+100 mg Raw

WEEK #7-WEEK #12 (ADVANCED STAGES)

Morning:

+Frozen 0.5 ounce of proprietary blend of Fresh Frozen Raw CannabisJuice (100 mg Raw) or Powdered Raw Cannabis Juice added to apple juice,super smoothie, or anti-inflammatory juice beverage.

+100 mg Prana P1 Capsules

Afternoon:

+100 mg Prana P2 Capsules

Dinner:

+100 mg Prana P3 Capsules

Bedtime: (30 min Prior)

+100 mg Prana P4 Capsules

Example 7 Exemplary Protocol For Anxiety/PTSD

Morning

+5 mg-10 mg Prana P2 CBD AM Capsules (2:1 to 3:1, THC:CBD)

+2 mg to 4 mg Prana P4 CBD:CBN Sublingual (1:1)

Afternoon:

+2 mg to 4 mg Prana P4 CBD:CBN Sublingual (1:1)

+Used when feeling anxiety or PSTD throughout the day.

After Dinner:

+5 mg-10 mg Prana P3 CBD PM Capsules (2:1 to 1:1, THCa:CBDa)

+4 mg Prana P4 CBD:CBN Sublingual (1:1)

Bedtime:

+10 mg Prana P4 CBN Capsules

Example 8 Exemplary Protocol For Chronic Pain

Morning:

+5 mg Prana P2 CBD AM Capsules (2:1 to 3:1, THC:CBD)

+2 mg to 4 mg Prana P1 THCa Sublingual

Afternoon:

+5 mg Prana P2 CBD AM Capsules (2:1 to 3:1, THC:CBD)

+2 mg to 4 mg Prana P1 THCa Sublingual (As Needed)

Dinner:

+10 mg Prana P3 CBD PM Capsules (2:1 to 1:1, THCa:CBDa)

+2 mg to 4 mg Prana P1 THCa Sublingual

Bedtime:

+10 mg Prana P4 CBN Capsules

Example 9 Exemplary Protocol For Opiate Dependency

Note: This is a 16 week program.

WEEK #1 & WEEK #2

Morning:

+Prana P5—100 gms raw or 10 gms powder

+5 mg Prana P1 Prana Capsule

+2 mg Prana P2 CBD AM Sublingual (2:1 to 3:1, THC:CBD)

Afternoon:

+5 mg Prana P1 Prana Capsule

+2 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Dinner:

+5 mg Prana P1 Prana Capsule

+2 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Bedtime: (30 min Prior)

+10 mg Prana P3 CBD PM Capsules (2:1 to 1:1)

+2 mg Prana P4 Sublingual CBD:CBN (1:1)

TOTAL CANNABINOIDS DAILY: 31 mg+50 mg Raw

REDUCE OPIATES BY 10%-20%

WEEK #3 & WEEK #4

Morning:

+Prana P5—100 gms raw or 10 gms powder

+10 mg Prana P1 Capsules

+4 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Afternoon:

+10 mg Prana P1 THCa Capsules

+4 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Dinner:

+10 mg Prana P1 THCa Capsules

+4 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Bedtime: (30 min Prior)

+10 mg Prana P3 CBD PM Capsules (2:1 to 1:1)

+4 mg Prana P4 Sublingual CBD:CBN (1:1)

TOTAL CANNABINOIDS ABSORBED DAILY: 56 mg+50 mg Raw

REDUCE OPIATES BY 10%-20%

WEEK #5 & WEEK #6

Morning:

+Prana P5—100 gms raw or 10 gms powder

+15 mg Prana P1 THCa Capsules

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Afternoon:

+15 mg Prana P1 THCa Capsules

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Dinner:

+15 mg Prana P1 THCa Capsules

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Bedtime: (30 min Prior)

+15 mg Prana P3 CBD PM Capsules (2:1 to 1:1)

+6 mg Prana P4 Sublingual CBD:CBN (1:1)

TOTAL CANNABINOIDS ABSORBED DAILY: 84 mg+50 mg Raw

REDUCE OPIATES BY 10%-20%

WEEK #7 & WEEK #8

Morning:

+Prana P5—100 gms raw or 10 gms powder

+20 mg Prana P1 Prana Capsule

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Afternoon:

+20 mg Prana P1 Prana Capsule

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Dinner:

+20 mg Prana P1 THC Capsules

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Bedtime: (30 min Prior)

+20 mg Prana P3 CBD PM Capsules (2:1 to 1:1)

+6 mg Prana P4 Sublingual CBD:CBN (1:1)

TOTAL CANNABINOIDS ABSORBED DAILY: 104 mg+50 mg Raw

REDUCE OPIATES BY 10%-20%

WEEK #8 & WEEK #9

Morning:

+Prana P5—100 gms raw or 10 gms powder

+15 mg Prana P1 Prana Capsule

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Afternoon:

+15 mg Prana P1 Prana Capsule

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Dinner:

+15 mg Prana P1 Prana Capsule

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Bedtime: (30 min Prior)

+20 mg Prana P3 CBD PM Capsules (2:1 to 1:1)

+6 mg Prana P4 Sublingual CBD:CBN (1:1)

TOTAL CANNABINOIDS ABSORBED DAILY: 89 mg+50 mg Raw

REDUCE OPIATES BY 10%-20%

WEEK #10 & WEEK #11

Morning:

+Prana P5—100 gms raw or 10 gms powder

+10 mg Prana P1 Prana Capsule

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Afternoon:

+10 mg Prana P1 Prana Capsule

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Dinner:

+10 mg Prana P1 Prana Capsule

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Bedtime: (30 min Prior)

+15 mg Prana P3 CBD PM Capsules (2:1 to 1:1)

+6 mg Prana P4 Sublingual CBD:CBN (1:1)

TOTAL CANNABINOIDS ABSORBED DAILY: 69 mg+50 mg Raw

REDUCE OPIATES BY 10%-20%

WEEK #12 & WEEK #13

Morning:

+Prana P5—100 gms raw or 10 gms powder

+5 mg Prana P1 Prana Capsule

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Afternoon:

+5 mg Prana P1 Prana Capsule

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Dinner:

+5 mg Prana P1 Prana Capsule

+6 mg Prana P2 CBD AM Sublingual (2:1 to 3:1)

Bedtime: (30 min Prior)

+10 mg Prana P3 CBD PM Capsules (2:1 to 1:1)

+6 mg Prana P4 Sublingual CBD:CBN (1:1)

TOTAL CANNABINOIDS ABSORBED DAILY: 49 mg+50 mg Raw

REDUCE OPIATES BY 10%-20%

WEEK #14 & WEEK #15

Morning:

+Prana P5—100 gms raw or 10 gms powder

+4 mg Prana P1 THCa Sublingual

+5 mg Prana P2 CBD AM Capsule (2:1 to 3:1)

Afternoon:

+4 mg Prana P1 THCa Sublingual

+5 mg Prana P2 CBD AM Capsule (2:1 to 3:1)

Dinner:

+4 mg Prana P1 THCa Sublingual

+5 mg Prana P2 CBD AM Capsule (2:1 to 3:1)

Bedtime: (30 min Prior)

+10 mg Prana P3 CBD PM Capsules (2:1 to 1:1)

+4 mg Prana P4 Sublingual CBD:CBN (1:1)

TOTAL CANNABINOIDS ABSORBED DAILY: 41 mg+50 mg Raw

OPIATES SHOULD BE REDUCED BY 80-90%

WEEK #16+

+Every 3rd Day+Prana P5—100 gms raw or 10 gms powder

Morning:

+10 mg Prana P2 CBD AM Capsule (2:1 to 3:1)

+4 mg Prana P1 THCa Sublingual (Only As Needed for Pain)

Afternoon:

+4 mg Prana P1 THCa Sublingual (Only As Needed for Pain)

Dinner:

+10 mg Prana P3 CBD PM Capsule (2:1 to 1:1)

+4 mg Prana P1 THCa Sublingual (Only As Needed for Pain)

Bedtime: (30 min Prior)

+4 mg Prana P4 Sublingual CBD:CBN (1:1)

TOTAL CANNABINOIDS ABSORBED DAILY: 36 mg+25 mg Raw

OPIATES SHOULD BE REDUCED BY 90%-100%.

Other Embodiments

While the invention has been described in conjunction with the detaileddescription thereof, the foregoing description is intended to illustrateand not limit the scope of the invention, which is defined by the scopeof the appended claims. Other aspects, advantages, and modifications arewithin the scope of the following claims.

What is claimed is:
 1. A method for relieving symptoms associated withanxiety, post traumatic stress disorder, chronic pain, or opiatedependency, paralysis, neuropathy, Crohns disease, inflammatory boweldisorders, glaucoma, seizures, epilepsy, autism, or cancer comprisingadministering to a subject at least four daily doses of a cannabinoidformulation, wherein at least two of the at least four daily dosescomprise different cannabinoid formulations selected from the group ofcannabinoid formulations consisting of: a. a formulation wherein atleast 95% of the total cannabinoids in the formulation istetrahydrocannabinolic acid (THCa); b. a formulation wherein at least95% of the total cannabinoids in the formulation is tetrahydrocannabinol(THC); c. a formulation wherein at least 95% of the total cannabinoidsin the formulation is cannabidiol (CBD); d. a formulation wherein atleast 95% of the total cannabinoids in the formulation are THCa andcannabidiolic acid (CBDa); e. a formulation wherein at least 95% of thetotal cannabinoids in the formulation are THC and CBD; f. a formulationwherein at least 95% of the total cannabinoids in the formulation areCBD, cannabinol (CBN) and THC; g. a formulation wherein at least 95% ofthe total cannabinoids in the formulation is cannabidiol (CBDa); h. aformulation wherein at least 95% of the total cannabinoids in theformulation is cannabichromene (CBC); i. a formulation wherein at least95% of the total cannabinoids in the formulation is cannabichromenicacid (CBCa); j. a formulation comprising at least 95%tetrahydrocannabinol (THC) as the only cannabinoid in the formulation;and k. a formulation wherein at least 95% of the total cannabinoids inthe formulation is tetrahydrocannabinol (THC) from cannabis indica orcannabis ruderalis.
 2. The method of claim 1, wherein the cannabinoidformulation further comprises least one terpene and/or flavonoid.
 3. Themethod of claim 2, wherein the cannabinoid formulation comprises no morethan 4% terpene.
 4. The method of claim 1, wherein at least 95% of thetotal cannabinoids in the formulation is cannabidiol (CBD) and theformulation comprises less than 1% THC.
 5. The method of claim 1,wherein at least 95% of the total cannabinoids in the formulation areCBD, cannabinol (CBN) and THC, wherein the formulation comprises lessthan 9% THC.
 6. The method of claim 1, wherein at least 95% of the totalcannabinoids in the formulation is tetrahydrocannabinolic acid (THCa),and the formulation comprises no more that 4% terpene.
 7. The method ofclaim 1, wherein at least 95% of the total cannabinoids in theformulation is tetrahydrocannabinol.
 8. The method of claim 6 or 7,wherein the terpene in the formulation comprises a mixture of myrcene,caryophyllene, and limonene.
 9. The method of claim 1, wherein at least95% of the total cannabinoids in the formulation is cannabidiol (CBD),and the formulation comprises no more than 4% terpene.
 10. The method ofclaim 9, wherein the terpene in the formulation comprises a mixture ofmyrcene, caryophyllene, and limonene.
 11. The method of claim 1, whereinat least 95% of the total cannabinoids in the formulation are THCa andcannabidiolic acid (CBDa) and the formulation comprises no more than 4%terpene.
 12. The method of claim 1, wherein at least 95% of the totalcannabinoids in the formulation are THC and CBD and the formulationcomprises no more than 4% terpene.
 13. The method of claim 11 or 12,wherein the terpene in the formulation comprises a mixture of limonene,pinene, and caryophyllene.
 14. The method of claim 11 or 12, wherein theterpene in the formulation comprises a mixture of myrcene, limonene,pinene, and caryophyllene.
 15. The method of claim 1, wherein at least95% of the total cannabinoids in the formulation are CBD, cannabinol(CBN) and THC and the formulation comprises no more than 4% terpene. 16.The method of claim 15, wherein the terpene in the formulation comprisesa mixture of myrcene, pinene and caryophyllene.
 17. The method of claim1, wherein the cannabinoid formulation is infused in a medium chaintriglyceride.
 18. The method of claim 1, wherein the pH of thecannabinoid formulation is at least pH 8.0.
 19. The method of claim 1,wherein the formulation is administered in the morning; the afternoon;evening and at bedtime.
 20. The method of claim 1, wherein the dosecomprises a dosage form of a pump-action liquid, an aerosol spray, atablet, a pastille, a gel, a capsule, a suppository, a powder or avaporizer.